OPUS(R) VANCOMYCIN
Device Facts
| Record ID | K924957 |
|---|---|
| Device Name | OPUS(R) VANCOMYCIN |
| Applicant | Pb Diagnostic Systems, Inc. |
| Product Code | LEH · Clinical Toxicology |
| Decision Date | Dec 11, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3950 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
